MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG OBL H12MM 30X33MM 10; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to ldr medical, no visual examination can be performed.Regarding information provided, cage was loaded incorrectly on inserter.Investigation still in progress to determine the root cause of this event.

Event Description

As reported during a roi-a surgery : cage broke during impaction, before implanting anchors.Surgeon removed it and put another one.No impact on patient.Suspected issue: cage was incorrectly loaded on inserter (inverted threaded rods).

Manufacturer Narrative

Without a product return, no product evaluation can be conducted.The review traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Regarding information provided, root cause is related to a failure to follow surgical technique, cage was loaded incorrectly on inserter.The investigation found no evidence to indicate a device issue.As indicated into roi-a surgical technique : during cage preparation step "bring the implant holder close to the cage: the threaded rod faces the threaded hole located close to the marker.The pin of the cage holder is then inserted into the smooth hole of the cage.".

Event Description

As reported: during a roi-a surgery, cage broke during impaction, before implanting anchoring plates.Surgeon removed it and put another one.No impact on patient.Issue probably due to cage incorrectly loaded on inserter.Threaded rod of implant holder was inserted into the smooth hole of the cage and the pin of cage holder was inserted into the threaded hole.

• Brand Name: ROI-A CAG OBL H12MM 30X33MM 10
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7370156
• MDR Text Key: 103688453
• Report Number: 3004788213-2018-00083
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR4332P
• Device Lot Number: 494837R11
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention